BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LOCK FLUSH, USP 100 UNITS/ML 5ML SYRINGE

    MDR report key: 1040353 · Received May 9, 2008

    Report

    Report Number
    MW5006795
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 23, 2008
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED NAUSEA AND BAD TASTE IN MOUTH FOLLOWING HEPARIN FLUSHES. PT IS BEING TREATED FOR HYPEREMESIS GRAVIDARUM AND WAS 10 WEEKS PREGNANT AT TIME OF ADVERSE REACTION. PATIENT HAD BEEN FLUSHING PICC LINE WITH HEPARIN 1 TO 3 TIMES A DAY WITH 3 ML OF THE 500 UNITS / 5ML PREFILL FLUSH SYRINGE FROM EXCELSIOR MEDICAL FOLLOWING IV FLUIDS OR ANTI-EMETICS. PACKAGE INSERT FOR THIS PRODUCT ALSO CONTAINS RECOMMENDATION TO LOWER RATE OF INFUSION TO MINIMIZE UNPLEASANT TASTE PATIENT MAY EXPERIENCE. PATIENT WAS ON IV FLUIDS (D5LR 1-2 LITERS/DAY), MULTIVITAMIN IV ADDED TO 1 LITER DAILY, ONDANSETRON 8MG IV TID PRN AND USING SALINE - MEDICATION OR IV FLUID - HEPARIN FLUSHING PROTOCOL. DUE TO ADVERSE REACTION, HEPARIN FLUSHING WAS DC'D ON THE PATIENT AND PATIENT CHANGED TO SALINE ONLY FLUSHES BEFORE AND AFTER. DOSE OR AMOUNT: 500 UNITS/ 5 ML; FREQUENCY: QD; ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: HYPEREMESIS GRAVIDARUM. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH, USP 100 UNITS/ML 5ML SYRINGE NONE NZW 61-052-9D

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR